Non-blinded study

Non-blinded designs are sometimes unavoidable for devices, for example when a surgical procedure cannot be hidden. The sponsor is then expected to limit the resulting bias, for instance with blinded outcome assessors or objective endpoints.

A study in which there is no blinding; also called an open-label study (see also Open-Label Study).

FDA guidance: Design Considerations for Pivotal Clinical Investigations for Medical Devices (November 2013), Section 11, Glossary